Bonafix TWO - 牙齒植體系統
K 號：K162853 · 2017-07-14
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器材摘要
Bonafix TWO - Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bonafix Surgical and Dental Implants. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162853. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bonafix TWO - Dental Implant System?
Bonafix TWO - Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Bonafix Surgical and Dental Implants. The 510(k) number is K162853.
When did Bonafix TWO - Dental Implant System receive FDA 510(k) clearance?
Bonafix TWO - Dental Implant System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162853.
Who is the listed applicant for Bonafix TWO - Dental Implant System?
The FDA 510(k) record lists Bonafix Surgical and Dental Implants as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bonafix TWO - Dental Implant System?
The FDA product code for Bonafix TWO - Dental Implant System is DZE.
相關臨床試驗
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相關器械（代碼：DZE）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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